FDA has posted a draft guidance to help persons submitting applications for new tobacco products understand the premarket tobacco product application process. The draft guidance addresses questions such as: • Who may submit a new tobacco product application • When to submit a new tobacco product application • What information the FD&C Act requires you…
E-Cigarettes Versus Oregon
Smoking Everywhere, a distributor of electronic cigarettes has agreed to cease sales in the State of Oregon, following a lawsuit settlement, the Miami Herald reported. Oregon last year became the first state to go to court to attempt to block the sale of the devices. Attorney General John Kroger said Smoking Everywhere did not seek…
Federal Judge Sides With Electronic Cigarettes
A U.S. judge has ruled that the U.S. Food and Drug Administration (FDA) does not have the authority to regulate electronic cigarettes, The Wall Street Journal reported. In a 32-page opinion, U.S. District Judge Richard J. Leon sided with electronic cigarette maker Smoking Everywhere Inc., and found that the FDA did not have the authority…